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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K220250
Device Name Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Applicant
Grand Work Plastic Products Co., Ltd.
Donggao Industrial Zone, Zanhuang
Shijiazhuang,  CN 050000
Applicant Contact Wu Yuli
Correspondent
Hongray USA Medical Products, Inc.
3973 Schaefer Ave.,
Chino,  CA  91710
Correspondent Contact Kathy Liu
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received01/31/2022
Decision Date 05/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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